10,000 results · 87ms · Sources: EU EUDAMED, US FDA

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PHILIPS RESPIRONICS DREAMSTATION

FDA Adverse Event
Injury ·PHILIPS / RESPIRONICS, INC.·Product code BZD·February 22, 2022

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 22, 2021

COVID 19 HOME TEST

FDA Adverse Event
Malfunction ·ELLUME LIMITED·Product code QKP·January 24, 2022

COBAS 8000 E 801 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 9, 2022

COBAS PRO ISE ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 15, 2024

PRIMEADVANCED

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·April 17, 2012

CENTRAL LINE

FDA Adverse Event
Injury ·Product code FOZ·October 8, 2021

AXSYM CORE REAGENT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code LOM·January 27, 2009

SIMPLEXA COVID-19 DIRECT ASSAY

FDA Adverse Event
Malfunction ·DIASORIN MOLECULAR LLC·Product code QJR·May 25, 2021

VIDAS SARS-COV-2 IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code QKO·June 24, 2021

SIMPLEXA COVID-19 DIRECT ASSAY

FDA Adverse Event
Malfunction ·DIASORIN MOLECULAR LLC·Product code QJR·November 10, 2021

ORTHO VISION ANALYZER

FDA Adverse Event
Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·June 3, 2021

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code JJE·April 9, 2021

ARCHITECT C4000

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·July 23, 2024

ARCHITECT C16000

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·July 10, 2024

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·December 24, 2025

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·December 17, 2025

ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·December 22, 2025

APTIMA HIV-1 QUANT DX ASSAY

FDA Adverse Event
Injury ·HOLOGIC, INC.·Product code MZF·December 2, 2025

SARS-COV-2 IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code QKO·September 10, 2020